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Soma (Carisoprodol) Information:

WHAT IT IS

Soma is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain.

IMPORTANT INFORMATION

Use caution when driving, operating machinery, or performing other hazardous activities. Aspirin / carisoprodol / codeine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. • Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking aspirin / carisoprodol / codeine. Also, in combination with aspirin, alcohol can be very damaging to your stomach. • Watch for bloody, black, or tarry stools or blood in your vomit. This could mean damage to your stomach. • Never take more of this medication than is prescribed for you. If your pain is not being adequately treated, talk to your doctor.

HOW TO USE THIS MEDICATION

Take carisoprodol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. • Take each dose with a full glass of water. • The maximum amount of aspirin / carisoprodol / codeine you should take in one day is 1600 mg of carisoprodol, 2600 mg of aspirin, and 128 mg of codeine (eight tablets). • Store aspirin / carisoprodol / codeine at room temperature away from moisture and heat.

CAUTIONS

Do not take aspirin / carisoprodol / codeine if you have acute intermittent porphyria. • Codeine is habit forming and should only be used under close supervision if you have an alcohol or drug addiction. • Before taking this medication, tell your doctor if you have · kidney disease, · liver disease, · an ulcer in your stomach or intestines, · a bleeding or blood-clotting disorder, · urinary retention, · an enlarged prostate, · hypothyroidism, · a head injury, or · Addison’s disease. • You may not be able to take aspirin / carisoprodol / codeine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above. • It is not known whether aspirin and aspirin / carisoprodol / codeine will harm an unborn baby. Do not take aspirin and aspirin / carisoprodol / codeine without first talking to your doctor if you are pregnant. • It is also not known whether aspirin and aspirin / carisoprodol / codeine passes into breast milk. Do not take aspirin and aspirin / carisoprodol / codeine without first talking to your doctor if you are breast-feeding a baby. • Aspirin / carisoprodol / codeine is not approved for use in children younger than 12 years of age.

SIDE EFFECTS

If you experience any of the following serious side effects, stop taking aspirin / carisoprodol / codeine and seek emergency medical attention: · an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); · paralysis (loss of feeling) or extreme weakness; · vision loss; · agitation or tremor; · red, black, or bloody stools; or · blood in your vomit. • Other, less serious side effects may be more likely to occur. Continue to take aspirin / carisoprodol / codeine and talk to your doctor if you experience · drowsiness or dizziness; · headache; · depression; · blurred vision or small pupils; · insomnia; · hiccups; · faint ringing in the ears; or · nausea, vomiting, or constipation. • Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

DRUG INTERACTIONS

Many drugs can increase the effects of aspirin / carisoprodol / codeine and lead to heavy sedation. Before taking this medication, tell your doctor if you are taking any of the following medicines: · antihistamines such as brompheniramine (Dimetane, Bromfed, others), chlorpheniramine (Chlor-Trimeton, Teldrin, others), azatadine (Optimine), clemastine (Tavist), and many others; · narcotics (pain killers) such as meperidine (Demerol), morphine (MS Contin, MSIR, others), propoxyphene (Darvon, Darvocet), hydrocodone (Lorcet, Vicodin), oxycodone (Percocet, Percodan), fentanyl (Duragesic), and codeine (Fiorinal, Fioricet, Tylenol #3, others); · sedatives such as phenobarbital (Solfoton, Luminal), amobarbital (Amytal), and secobarbital (Seconal); · phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Prolixin), mesoridazine (Serentil), perphenazine (Trilafon), prochlorperazine (Compazine), thioridazine (Mellaril), and trifluoperazine (Stelazine); or · antidepressants such as doxepin (Sinequan), imipramine (Tofranil), nortriptyline (Pamelor), fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), phenelzine (Nardil), and tranylcypromine (Parnate). • Aspirin will decrease the effects of some drugs. Tell your doctor and pharmacist that you are taking aspirin / carisoprodol / codeine if any of the following drugs have been prescribed for you: · probenecid (Benebid) and sulfinpyrazone (Anturane); · angiotensin-converting-enzyme (ACE) inhibitors used to treat high blood pressure and other heart conditions such as benazepril (Lotensin), captopril (Capoten), and enalapril (Vasotec); · other commonly used ACE inhibitors, including fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), and ramipril (Altace); and · beta-blockers used to treat high blood pressure and other heart conditions such as acebutolol (Sectral), metoprolol (Lopressor), propranolol (Inderal), atenolol (Tenormin), and carteolol (Cartrol). • Other over-the-counter and prescription drugs may increase the effects of aspirin and cause dangerous side effects: · oral anticoagulants such as warfarin (Coumadin); · nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin, Rufen, others), ketoprofen (Orudis, Oruvail), and naproxen (Anaprox, Naprosyn, Aleve) · other commonly used NSAIDs, including diclofenac (Voltaren, Cataflam), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), and tolmetin (Tolectin); · other salicylates (forms of aspirin) such as salsalate (Disalcid), choline salicylate, and magnesium salicylate; · bismuth subsalicylate in drugs such as Pepto-Bismol; and · calcium supplements and antacids. • Other drugs that should not be combined with aspirin and carisoprodol include · steroids such as prednisone (Deltasone), · oral antidiabetic drugs such as glipizide (Glucotrol) and glyburide (Micronase, Diabeta), · alcohol, · lithium (Lithobid, Eskalith, others), and · cyclosporine (Sandimmune). • Drugs other than those listed here may also interact with aspirin / carisoprodol / codeine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

MISSED DOSE

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication. Keep your doses at least 4 hours apart from one another.

IF YOU TAKE TOO MUCH

Seek emergency medical attention. • Symptoms of an aspirin / carisoprodol / codeine overdose include headache; ringing in the ears; dim vision, small pupils; nausea; vomiting; diarrhea; sweating; increased thirst; low blood pressure (weakness, fainting, confusion); decreased breathing; and unconsciousness.